Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001429842
Ethics application status
Approved
Date submitted
27/09/2021
Date registered
21/10/2021
Date last updated
30/09/2022
Date data sharing statement initially provided
21/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A telehealth-supported falls prevention program for people with stroke returning home from hospital
Scientific title
A mixed-methods pilot study investigating a multifactorial telehealth-supported falls prevention program for people with stroke transitioning home
Secondary ID [1] 305338 0
Nil known
Universal Trial Number (UTN)
U1111-1269-4999
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 323660 0
Falls risk 323661 0
Condition category
Condition code
Stroke 321197 321197 0 0
Ischaemic
Stroke 321198 321198 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 321199 321199 0 0
Physiotherapy
Physical Medicine / Rehabilitation 321200 321200 0 0
Occupational therapy
Injuries and Accidents 321524 321524 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: A multifactorial telehealth-supported falls prevention intervention for people with stroke transitioning home.

Description: The intervention will involve a 4-week program provided in addition to usual care following discharge from an inpatient service. This will include a comprehensive assessment of falls risk (e.g., physical function, cognition, medications and home safety) and development of a tailored program using behaviour change techniques (e.g., shared goal setting and problem solving). The initial session will be conducted in the person's home within one week post discharge. With the exception of one in-person visit, all follow-up sessions will occur via telehealth (video or phone call), 30-45 minutes, twice weekly for four weeks. The intervention sessions will be undertaken by physiotherapists (>5 years experience), and will include falls prevention education, a tailored exercise program, discussion of goals and strategies, and engagement of other disciplines as required (e.g., environmental modifications and medication management). The research team will record the number and duration of all intervention and usual care sessions, and the participants will record the number and duration of falls prevention exercise sessions.
Intervention code [1] 321748 0
Prevention
Intervention code [2] 321749 0
Rehabilitation
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328991 0
Adherence to the study plan in terms of the provision of in-person and telehealth sessions (documentation of the number and length of sessions, including supervised exercise component, in the electronic medical record and study database)
Timepoint [1] 328991 0
4 weeks post intervention commencement.
Primary outcome [2] 329290 0
Adherence to the study plan in terms of independent exercise sessions (participant logbook to record number and length, checked by researcher weekly and recorded in study database).
Timepoint [2] 329290 0
4 weeks post intervention commencement.
Primary outcome [3] 329291 0
Adherence to the study plan in terms of falls prevention recommendations (documentation of number and proportions in the study database).
Timepoint [3] 329291 0
4 weeks post intervention commencement.
Secondary outcome [1] 401048 0
Participant acceptability, assessed by surveys and semi-structured interviews with thematic analysis.

The surveys include the 'Telehealth Usability Questionnaire' (Parmanto et al, 2016) and a 'Perceived usefulness and satisfaction questionnaire' (8 items with 5-point Likert scale responses designed specifically for this study).

The one-on-one semi-structured interviews will occur via phone or video conferencing. and will take between 30 to 45 minutes duration. The interviews will be audio-recorded and transcribed prior to independent analysis by 2 researchers using both an inductive and deductive lens.
Timepoint [1] 401048 0
Within 3 weeks of program completion (i.e., between Week 4 and Week 7 post intervention commencement).
Secondary outcome [2] 401049 0
Safety, assessed by asking about and documenting any falls or other events leading to the need for medical attention both related or unrelated to the intervention or study procedures.
Timepoint [2] 401049 0
Assessed each session throughout the 4-week program (i.e., twice weekly).
Secondary outcome [3] 401050 0
Response rate (proportion of eligible participants who consent and reasons for not consenting).
Timepoint [3] 401050 0
At study completion.
Secondary outcome [4] 401051 0
Intervention delivery costs, including therapist salary costs (determined by actual salary costs and documented time), equipment and resources.
Timepoint [4] 401051 0
At study completion.
Secondary outcome [5] 401052 0
Short Physical Performance Battery (physical function).
Timepoint [5] 401052 0
Baseline and 4 weeks post intervention commencement.
Secondary outcome [6] 401053 0
Step Test (dynamic balance).
Timepoint [6] 401053 0
Baseline and 4 weeks post intervention commencement..
Secondary outcome [7] 401054 0
Timed Up and Go (mobility and dynamic balance).
Timepoint [7] 401054 0
Baseline and 4 weeks post intervention commencement..
Secondary outcome [8] 401055 0
Short Falls Efficacy Scale - International.
Timepoint [8] 401055 0
Baseline and 4 weeks post intervention commencement..
Secondary outcome [9] 401056 0
Home Falls and Accidents Screening Tool - Health Professional (HOME FAST-HP).
Timepoint [9] 401056 0
Baseline and 4 weeks post intervention commencement..
Secondary outcome [10] 401057 0
EQ-5D-5L (quality of life).
Timepoint [10] 401057 0
Baseline and 4 weeks post intervention commencement..
Secondary outcome [11] 402052 0
Study attrition (number and reasons for withdrawals or missed assessment sessions).
Timepoint [11] 402052 0
At study completion.

Eligibility
Key inclusion criteria
Adults who have been admitted to hospital due to stroke and deemed at risk of falls post discharge home from the inpatient setting (i.e., Berg Balance Scale < 49 or Step Test < 7 within one week prior to discharge or occurrence of fall during inpatient stay). Able to walk (with or without assistance; Functional Ambulation Category > 0). Availability of adequate support and access to technology to undertake telehealth sessions from home. Referred to follow-up therapy provided by the service (i.e., within the service catchment area).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inadequate understanding or capability to participate in informed consent or study procedures (e.g., due to language (i.e., requiring an interpreter or having moderate-severe receptive or severe expressive dysphasia), cognitive, vision or hearing issues). Any other medical conditions that would prohibit participation in a home exercise program (e.g., unstable angina).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
We aim to recruit 16 participants based on anticipated feasibility of recruitment and analysis given the time frame and resource availability (i.e., 4-5 participants per month over a 4-month period). Recruiting 16 participants provides 80% power to correctly identify if the program is feasible; assuming at least 80% of patients manage to complete the program to an acceptable level (completing 50% supervised and independent exercise sessions) at a 5% significance level.

Descriptive statistics will be used to evaluate:
• Adherence to the study plan
• Acceptability and implementation barriers/facilitators
• Safety
• Response rate and attrition
• Costs of program

Descriptive statistics with confidence intervals, supported by paired t-tests or Wilcoxon signed-rank tests (for parametric or non-parametric data respectively) will be used to evaluate changes between baseline and 4 weeks:
• Physical function, balance and mobility
• Short Falls Efficacy Scale – International
• Quality of life
• Home environmental safety

Reflexive thematic analysis will be used to explore intervention acceptability in addition to implementation barriers and facilitators. Semi-structured interviews will be conducted with participants. This will be analysed using both an inductive approach and deductive lens (according to existing theoretical frameworks). Two researchers will contribute to data analysis at each stage.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/10/2021
Actual
22/10/2021
Date of last participant enrolment
Anticipated
27/04/2022
Actual
10/08/2022
Date of last data collection
Anticipated
8/06/2022
Actual
16/09/2022
Sample size
Target
16
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 20550 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 20551 0
Royal Melbourne Hospital - Royal Park campus - Parkville
Recruitment postcode(s) [1] 35332 0
3050 - Parkville
Recruitment postcode(s) [2] 35333 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 309707 0
University
Name [1] 309707 0
The University of Melbourne
Country [1] 309707 0
Australia
Primary sponsor type
Hospital
Name
The Royal Melbourne Hospital
Address
300 Grattan St, Parkville, Victoria 3050
Country
Australia
Secondary sponsor category [1] 310727 0
None
Name [1] 310727 0
Address [1] 310727 0
Country [1] 310727 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309470 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 309470 0
Ethics committee country [1] 309470 0
Australia
Date submitted for ethics approval [1] 309470 0
24/05/2021
Approval date [1] 309470 0
06/07/2021
Ethics approval number [1] 309470 0
HREC/75397/MH-2021

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114262 0
Dr Kelly Bower
Address 114262 0
The University of Melbourne
Department of Physiotherapy, Melbourne School of Health Sciences
Level 6, 161 Barry Street, Alan Gilbert Building
Grattan St, Parkville, Victoria 3010
Country 114262 0
Australia
Phone 114262 0
+61438395155
Fax 114262 0
Email 114262 0
[email protected]
Contact person for public queries
Name 114263 0
Kelly Bower
Address 114263 0
The University of Melbourne
Department of Physiotherapy, Melbourne School of Health Sciences
Level 6, 161 Barry Street, Alan Gilbert Building
Grattan St, Parkville, Victoria 3010
Country 114263 0
Australia
Phone 114263 0
+61438395155
Fax 114263 0
Email 114263 0
[email protected]
Contact person for scientific queries
Name 114264 0
Kelly Bower
Address 114264 0
The University of Melbourne
Department of Physiotherapy, Melbourne School of Health Sciences
Level 6, 161 Barry Street, Alan Gilbert Building
Grattan St, Parkville, Victoria 3010
Country 114264 0
Australia
Phone 114264 0
+61438395155
Fax 114264 0
Email 114264 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a small feasibility study and it would be difficult to protect anonymity if individual participant data is shared. The consent form states that information will only be used for the purpose of this research project.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.